Oxcia reports positive interim data from the first part of the MASTIFF study, a phase 1 dose- escalation study with OXC-101 in patients with advanced solid cancers. Oxcia is a pioneer in oxidative DNA damage and DNA Damage Response (the body’s processes for repairing the damage that occurs to DNA) with a focus on developing new safe treatments for cancer or inflammation.
OXC-101 has a unique mechanism of action that fights cancer by utilizing the cancer’s inherently high levels of oxidative DNA damage and oxidative stress. OXC-101 induces cancer-specific oxidative stress and oxidative DNA damage and prevents the cancer cell from growing. The result is that the cancer cell dies. Healthy cells are only marginally affected, which lays the foundation for OXC-101 high tolerability.
The primary purpose of the Phase 1 study is to evaluate safety and tolerability and to establish the optimal dose of OXC-101 in patients with advanced tumor disease. Patients were initially given an oral solution of OXC-101 in increasing doses (25mg-630mg). These 29 patients are included in the interim report. Currently and going forward, OXC-101 is given as a tablet. The patient population studied consists of patients with severe disease who’s cancers are still progressive after receiving several different standard therapies. The only treatment options for these patients are to participate in a clinical trial or to receive supportive palliative care.
In summary, study data show a very good safety profile and tolerability. No serious side effects have been reported. Neutropenia is the main side effect (the number of neutrophilic granulocytes in the blood is lowered and it becomes more difficult to defend the body against bacterial infections). Neutropenia is judged to be reversible and manageable.
The dose-escalation study is still open and new cohorts (patient groups) have been started and investigated to achieve the maximum tolerable dose and to establish the recommended dose for planned phase 2 studies.
Although the ongoing Phase 1 study is not primarily designed to show effect, preliminary effect data show promising results in a number of different diagnoses, such as uveal (eye) melanoma, endometrial (uterine body) cancer and rectal cancer. The effects will be measured in the planned phase 2 studies that will begin in Q4-22 / Q1-23.
A parallel Phase 1 study using OXC-101, MAATEO, investigates patients with advanced blood cancers. The MAATEO study was delayed due to the Covid pandemic. The staff situation has been and remains strained meaning that patient recruitment has been slower than planned. We have fortunately been able to open more study centers and the recruitment rate has improved. The first part of the study is expected to end in Q2-2022.
“Interim data supports the good safety and tolerability profile for OXC-101 and we are optimistic about further studies. The fact that OXC-101 is well tolerated in a group of patients who are already very frail and received many different treatment options prior to OXC-101, shows that there is good potential for OCX-101 to be significantly better tolerated than available treatments” says Ulrika Warpman Berglund, CEO of Oxcia.
For further information please contact:
Ulrika Warpman Berglund, CEO
Phone: +46 (0) 73 270 96 05
Email: ulrika.warpmanberglund@oxcia.com
Briefly about Oxcia
Oxcia AB is a pioneer in oxidative DNA damage and DNA Damage Response (DDR) with a focus on developing new safe treatments for patients suffering from diseases caused by cancer or inflammation. Oxcia currently has two DDR drug candidates, both with the potential to become first-in-class drugs. OXC-101 (Karonudib, TH1579) is being investigated in two ongoing clinical phase 1 studies, one in advanced solid tumors and one in hematological cancers. OXC-201 (TH5487) is developed against inflammatory and fibrosis-related diseases, such as pulmonary fibrosis, and is in the preclinical phase.
More information about Oxcia is available at www.oxcia.com